CORE PROPOSAL: The conceptual framework of this project is to provide a normative description of the ethical and policy issues raised by newborn genetic screening. This is a critical time given the rapidly evolving application of tandem mass spectrometry to screen newborns for a large number of inherited and metabolic conditions. Currently, there is wide variation between programs nationally and internationally. Why some screening programs have met with great acceptance and decreased morbidity whereas others have not needs to be understood to ensure that future expansions are ethically, and socially acceptable. The project will examine the factors that have led to the expansion and elimination of newborn screening in light of the complementary goals of equity, accessibility and accountability in genetic screening at the societal level and of consent, confidentiality, and disclosure at the personal level. OBJECTIVES: 1) to explore the wide array of ethical and policy issues raised by newborn genetic screening programs; 2) to learn what has worked and what has failed both logistically, politically, and clinically from the perspectives of the various stakeholders in various states and countries that have taken the lead in introducing particular screening programs; 3) to examine the clinical, psychosocial, ethical, economical, and reproductive implications of newborn genetic screening for conditions that present at various stages in the lifecycle; and 4) to examine the different implications that newborn genetic screening programs have for individuals, families, and communities; 5) to offer a normative analysis of the controversies that newborn genetic screening policies have and can generate; and 6) to develop principles to guide U.S. policy makers regarding newborn genetic screening program expansions and eliminations. RESEARCH DESIGN: Using a combination of publicly available documents and interviews with various stakeholders, the aim of the research is to offer a normative description of the ethical and policy issues raised by newborn genetic screening. The project will offer case study analyses from which principles to guide policy makers will be developed. OUTCOMES: The major outcomes will be a series of peer-reviewed articles and a full-length book entitled Newborn Genetic Screening: In whose Interest? For whose Benefit? [unreadable] [unreadable]